Identity
- Trade Name
- Exam Gown, 3 ply FDA UDI
- Generic Name
- Patient gown, single-use FDA UDI
- Device Name
- Exam Gown, 3-ply, T/P/T, Universal, Mauve FDA UDI
- Model / Reference
- 8103 FDA UDI
- Description
- Exam Gown, 3-ply, T/P/T, Universal, Mauve FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00616784810331 FDA UDI
- FDA Product Code
- FME FDA UDI
- GMDN Term
- Patient gown, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6265 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Patient gown, single-use
Exam Gown, 3 ply by Dynarex Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Encompass — Encompass Group, L.L.C. · Class I
- Encompass — Encompass Group, L.L.C. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Dynarex Corp.
Sources (1)
- FDA UDI a4934b99-7a49-4a56-a782-ac27f84cecba 33 fields · synced May 30, 2026